FRESENIUS PUNCTUR-GUARD FISTULA NEEDLE SETS— 510(k) K023162

Substantially Equivalent

Fresenius Medical Care

FDA 510(k) clearance K023162 for FRESENIUS PUNCTUR-GUARD FISTULA NEEDLE SETS, Substantially Equivalent on 2003-03-20. Applicant: Fresenius Medical Care.

Clearance details

Applicant: Fresenius Medical Care
Product code: Code FIE
Advisory panel: Gastroenterology, Urology
Date received: 2002-09-23
Decision date: 2003-03-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lexington, MA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code FIE

product code FIE

Death: 2
Total: 2

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.